Evidence map›Paper›PMID 30819224›Full record

SynthesisTrials2019

Statistical design and analysis in trials of proportionate interventions: a systematic review.

Jane Candlish, M Dawn Teare, Judith Cohen, Tracey Bywater

Abstract readSystematic Review
In one paragraph

Synthesis in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Jane CandlishScHARR, University of Sheffield, 30 Regent Court, Sheffield, S1 4DA, UK. jane.candlish@sheffield.ac.uk.ORCID http://orcid.org/0000-0001-5280-7891
M Dawn TeareScHARR, University of Sheffield, 30 Regent Court, Sheffield, S1 4DA, UK.
Judith CohenScHARR, University of Sheffield, 30 Regent Court, Sheffield, S1 4DA, UK.
Tracey BywaterDepartment of Health Sciences, University of York, Area 2, Seebohm, Rowntree Building, York, Y010 5DD, UK.

Funding

Department of Health PHR/13/93/10
6 · The paper itself

Abstract

backgroundIn proportionate or adaptive interventions, the dose or intensity can be adjusted based on individual need at predefined decision stages during the delivery of the intervention. The development of such interventions may require an evaluation of the effectiveness of the individual stages in addition to the whole intervention. However, evaluating individual stages of an intervention has various challenges, particularly the statistical design and analysis. This review aimed to identify the use of trials of proportionate interventions and how they are being designed and analysed in current practice.

methodsWe searched MEDLINE, Web of Science and PsycINFO for articles published between 2010 and 2015 inclusive. We considered trials of proportionate interventions in all fields of research. For each trial, its aims, design and analysis were extracted. The data synthesis was conducted using summary statistics and a narrative format.

resultsOur review identified 44 proportionate intervention trials, comprising 28 trial results, 13 protocols and three secondary analyses. These were mostly described as stepped care (n=37) and mainly focussed on mental health research (n=30). The other studies were aimed at finding an optimal adaptive treatment strategy (n=7) in a variety of therapeutic areas. Further terminology used included adaptive intervention, staged intervention, sequentially multiple assignment trial or a two-phase design. The median number of decision stages in the interventions was two and only one study explicitly evaluated the effect of the individual stages.

conclusionsTrials of proportionate staged interventions are being used predominantly within the mental health field. However, few studies consider the different stages of the interventions, either at the design or the analysis phase, and how they may interact with one another. There is a need for further guidance on the design, analyses and reporting across trials of proportionate interventions.

trial registrationProspero, CRD42016033781. Registered on 2 February 2016.

Indexed as

Data Interpretation, StatisticalModels, StatisticalClinical Trials as TopicEndpoint DeterminationHumansResearch DesignTreatment OutcomeAdaptive interventionAdaptive treatment strategyComplex interventionProportionate interventionProportionate universalismSequential multiple assignment randomised trialStepped careSystematic reviewTrial

Identifiers

PMID30819224
PMCPMC6396459

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.